Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Silvio O Conte Digestive Diseases Research Core Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-DK-09-005

Related Notices

  • September 8, 2011 - This RFA has been reissued as RFA-DK-11-022.
  • Funding Opportunity Announcement (FOA) Number

    RFA-DK-11-003

    Companion FOA

    None

    Number of Applications

    Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.

    Catalog of Federal Domestic
    Assistance (CFDA) Number(s)

    93.847  

    FOA Purpose

    This FOA issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs).  The DDRCCs are part of an integrated program of digestive and liver diseases research support provided by the NIDDK.  The purpose of this Centers program is to bring together basic and clinical investigators as a means to enhance communication, collaboration, and effectiveness of ongoing research related to digestive and/or liver diseases.  DDRCCs are based on the core concept, whereby shared resources aimed at fostering productivity, synergy, and new research ideas among the funded investigators are supported in a cost-effective manner.  Each proposed DDRCC must be organized around a central theme that reflects the digestive or liver diseases research focus of the center members. 

    Key Dates
    Posted Date
    Letter of Intent Due Date

    May 31, 2011

    Application Due Date(s)

    June 30, 2011

    AIDS Application Due Date(s)

    Not Applicable

    Scientific Merit Review

    November-December, 2011

    Advisory Council Review

    January, 2012

    Earliest Start Date(s)

    July, 2012

    Expiration Date

    July 1, 2011

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

    Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    The objective of the Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) is to bring together, on a cooperative basis, basic science and clinical investigators to enhance the effectiveness of their research related to digestive and/or liver diseases and their complications.  A core center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university.  An existing program of excellence in biomedical research in the area of digestive and/or liver diseases is a prerequisite for applying.  This research must be in the form of NIH research projects, program projects, or other peer-reviewed research that is already funded at the time of submission of a center grant application.  Close cooperation, communication, and collaboration among all involved personnel of various professional disciplines are the ultimate objectives.

    The DDRCCs are based on the core concept.  Cores are defined as shared resources that foster productivity and benefit a group of investigators working to accomplish the stated goals of the center. Three to six cores are usually included in a center.   Examples of core services/resources include, but are not limited to,  imaging facilities, transgenic animal units, and membrane, cell,  or tissue preparation laboratories.

    Centers are encouraged to include a clinical component to foster translational work.  This clinical component may exist as a stand-alone component or as a part of a core, such as the Administrative Core. Besides leading to a better understanding of the etiology and natural history of disease, clinical components might provide biostatistics support; enhance clinical study design; foster collaboration among researchers; aid in recruitment of subjects for clinical studies; support epidemiological studies in areas of digestive and/or liver diseases; or provide modest funding for tissue, DNA, or serum storage.  In addition, a clinical component may help effectively address NIH policies concerning women, children, and ethnic minority population participation in clinical studies.

    Three other types of activities also may be supported with center funding:  a Pilot and Feasibility (P/F) program, a Named New Investigator position, and an Enrichment Program.  The P/F program provides modest support for new initiatives or feasibility research studies.  This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to digestive or liver disease research, and, occasionally, at investigators already working in digestive or liver disease research who wish to make a substantial change in the direction of their work.  In addition, temporary salary support for one Named New Investigator in a specified area of research with a funded P/F study may be requested for up to 24 months. Subsequent individuals for this position will be selected by the center Director and approved by the center’s External Advisory Board and the NIDDK.  Limited funds for an Enrichment program to support seminars, visiting scientists, consultants, mini-sabbaticals, and workshops may also be requested.

    A DDRCC must have a central focus of research investigation. The central focus must be a gastrointestinal disease, group of diseases, or functional studies relating to digestive or liver diseases.  At least half of the research must relate to this central focus.  Examples of a gastrointestinal disease-related central focus of research investigation include, but are not limited to, inflammatory bowel disease, functional bowel disorders, pancreatic disease, liver disease, pediatric gastrointestinal disease, and AIDS in gastrointestinal disease. Examples of functional studies as the central focus include, but are not limited to, gastrointestinal motility, gastrointestinal hormones, role of the gastrointestinal tract in obesity, gastrointestinal physiology, or gene therapy for digestive or liver diseases.  Applicants should consult with NIDDK staff concerning plans for the development of the center and the organization of the application.

    Section II. Award Information
    Funding Instrument

    Grant

    Application Types Allowed

    New
    Renewal
    Resubmission

    The OER Glossary and the PHS398 Application Guide provide details on these application types.

    Award Budget

    Application budgets are limited to $750,000 direct costs, but need to reflect actual needs of the proposed Center.  Within the direct cost cap, up to $150,000 may be requested for the Pilot and Feasiibility program..

    Award Project Period

    The maximum project period is 5 years.

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

    Section III. Eligibility Information

    1. Eligible Applicants
     
    Eligible Organizations

    Higher Education Institutions:

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    Nonprofits Other Than Institutions of Higher Education

    For profit Organizations

    Governments

    Other

    Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.   

    A DDRCC must be an identifiable organizational unit within a single university medical center or within a consortium of cooperating institutions with a university affiliation.  The applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects related to digestive and/or liver diseases.  The research base must exist prior to the submission of the application.  This currently funded research base provides the major support for a group of investigators who would benefit from shared resources. The body of research described as the research base may include only currently funded, peer reviewed research grants awarded to the applicant institution. These may be Federally or privately funded awards.  Training grants and fellowship awards are not considered part of the research base.  Although collaborations with investigators outside the applicant institution/consortium are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium.

    Required Registrations

    Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

    All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

    All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

    Eligible Individuals (Project Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.    

    The DDRCC Director, who is the Principal Investigator of the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrated his/her proficiency in managing a large, multi-component program.  The Director will be responsible for the organization and operation of the DDRCC and for communicating with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend an annual meeting to be held at a location to be determined by the NIDDK.  

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility

    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

    Applicants may only submit one application in response to this FOA.

    Only institutions at which there is an ongoing, strong base of digestive and/or liver diseases-related research are eligible.  At least 50 percent of the already funded research base in a new application must be supported by the NIDDK.  In renewal applications, the NIDDK-supported research base may be less than 50 percent due, typically, to a growing number of investigators entering digestive or liver disease research from other fields.

    Applications for DDRCC grants must propose a theme for the center that is relevant to digestive or liver diseases and is supported by the research projects which comprise the research base for the DDRCC.  The research base grants should be summarized in accordance with the DDRCC guidelines found at http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm

    Scientific personnel and institutional resources capable of supporting the research base must be available.  In addition, the institution and pertinent departments must show a strong commitment to supporting the center.  Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated or shared equipment, or other financial support for the proposed center.

    Each proposed core must be utilized by a minimum of two federally funded investigators. A detailed description of each core proposed must be provided, including a detailed budget and budget justification.  A well-qualified core director must be named for each core.  The description of each core should include a rationale indicating how it will support the center’s research effort in a cost-effective manner. Facilities must be available for the primary needs of the DDRCC because funds for new construction are not available from the P30 grant.

    Section IV. Application and Submission Information

    1. Address to Request Application Package

    Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    Descriptive title of proposed research
    Name, address, and telephone number of the PD(s)/PI(s)
    Names of other key personnel
    Participating institutions
    Number and title of this funding opportunity

    The letter of intent should be sent to:

    Francisco O. Calvo, Ph.D.
    Chief, Review Branch
    National Institute of Diabetes and Digestive and Kidney Diseases
    6707 Democracy Boulevard, Room 752
    Bethesda, MD 20892-5452
    (for express/courier service: Bethesda, MD 20817)
    Telephone: (301) 594-8897
    Email: fc15y@nih.gov

    Application Submission

    Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

    Center for Scientific Review
    National Institutes of Health
    6701 Rockledge Drive, Room 1040, MSC 7710
    Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
    Bethesda, MD 20817 (for express/courier service; non-USPS service)

    At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

    Francisco O. Calvo, Ph.D.
    Chief, Review Branch
    National Institute of Diabetes and Digestive and Kidney Diseases
    6707 Democracy Boulevard, Room 752
    Bethesda, MD 20892-5452
    (for express/courier service: Bethesda, MD 20817)
    Telephone: (301) 594-8897
    Email: : fc15y@nih.gov

    Page Limitations

    All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

    Biographical Sketches

    Biographical sketches, following the instructions in the PHS 398,  must be provided for all center members, associate members, P/F  applicants, and named core personnel as well as members of external advisory committees and any consultants.  

    Research Plan

    All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

    Specific Aims

    The specific aims for a P30 DDRCC must succinctly state the goals of the DDRCC, its theme, and the rationale for requesting a core center as well as the need for the proposed cores. 

    Research Strategy

    The research strategy for a P30 DDRCC must include the following information, within the page limits indicated above:

    Resource Sharing Plan

    Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide,.

    Appendix

    Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

    3. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates. 

    Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

    Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

    4. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    5. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    Direct costs are limited to no more than $750,000. Within that amount, not more than $150,000 may be requested for the pilot and feasibility program.

    6. Other Submission Requirements and Information

    Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

    Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

    A DDRCC must be an identifiable organizational unit within a single university medical center or within a consortium of cooperating institutions with a university affiliation. To be responsive to this FOA,  the applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects related to digestive and/or liver diseases which exist at the time of submission.

    Scientific personnel and institutional resources capable of supporting the research base must be apparent.  Each proposed core must aim to support the research of at least two funded research base investigators.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115,

    Updated other support pages may be submitted prior to the review to better evaluate the research base.  At the discretion of the SRO, this may be in the format of an updated Exhibit III from the Administrative Guidelines for for Silvio O. Conte Digestive Diseases Centers (DDRCC) available on the internet at  http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRCCGuideTOC.htm ..

    Section V. Application Review Information

    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

    Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the P30 centert to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the P30 center proposed).

    Scored Review Criteria - Overall

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a core that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the P30 center address an important problem or a critical barrier to progress in the field? If the aims of the centert are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What are the strengths of the center's research base (its breadth and depth)?  Do the focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity of the research base support the stated theme of the center?  What is the likelihood that the DDRDC will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective? 

    Investigator(s)

    Are the PD/PIs, collaborators, and other researchers well suited to the center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the center investigators responsible for the individual research projects willing to interact with each other and contribute to the overall objectives of the DDRCC? What are the scientific and administrative leadership abilities of the proposed center Director and Associate Director(s) and their commitment and ability to devote adequate time to the effective management of the program? If requested, does the Named New Investigator appear well qualified and appropriate for support?

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are no more than four Pilot & Feasibility (P&F) studies submitted for evaluation as part of the review of the P&F program?  Are the P&F applicants eligible and does the selection process by which the individual studies were selected appear appropriate?  Does the center appear to encourage ‘high-risk’, innovative ideas through their P/F program? Have the cores provided new methods, techniques, and/or resources and developed ways to support investigators in new areas of digestive and/or liver diseases research, as appropriate to the purpose of the core and the research supported by the Center?  Have the cores adapted to the changing needs of the investigators?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the DDRCC? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

    If the DDRCCt involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?How appropriate and relevant are the proposed cores and the modes of operation (such as prioritization of requests for services)?  Will at least two funded investigators use each core? Will the cores provide opportunities not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches?  Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the center, including mechanisms for internal monitoring;(b) establishment and maintenance of internal communication and cooperation among the center investigators;(c) mechanism for selecting and replacing professional or technical personnel within the cores;(d) mechanism for reviewing the use of, and administering funds for, the P&F program;(e) management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities? Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to the stated goals of the center? 

    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

    Is there evidence of institutional support? Is there institutional commitment to the program, including lines of accountability, regarding management of the center grant and the institution's contribution to the management capabilities of the center? Is there clear potential for interaction with scientists from other departments and institutions?

    Additional Review Criteria - Overall

    As applicable for the DDRCC proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    Inclusion of Women, Minorities, and Children 

    When the proposed DDRCC involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period including:

    Have the benefits of the center been documented in the forms of increased collaboration, new research directions, and cost savings?

    Are data provided to document the outcome of all completed projects, including those that failed to lead to further funding?

    Have the cores provided new methods, techniques, and/or resources and developed ways to support investigators in new areas of digestive and/or liver diseases research, as appropriate to the purpose of the core and the research supported by the Center?

    Have the cores adapted to the changing needs of the investigators?

    Is the use, utility, quality control, and cost effectiveness of each core requested to continue as part of the center documented? 

    Are cores no longer needed appropriately being discontinued in response to the changing needs of center investigators?

    Is there a significant list of publications arising from each core in renewal applications?

    Has the administrative structure proven effective?

    Has the enrichment program been effective?

    Revisions

    Not applicable.

    Additional Review Considerations - Overall

    As applicable for the DDRCC proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

    Applications from Foreign Organizations

    Not applicable.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    Scored Sections of Application:

    For these P30 Center applications, reviewers will be asked to evaluate the following individual sections, and the Scientific Review Officer will record these scores:

    The overall impact score is not  the average of the scores for all these components.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

    As part of the scientific peer review, all applications:

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Diabetes, Digestive, and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information

    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

    Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

    A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.    

    Application Submission Contacts

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Telephone 301-435-0714
    TTY 301-451-5936
    Email: GrantsInfo@nih.gov

    eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
    Phone: 301-402-7469 or 866-504-9552 (Toll Free)
    TTY: 301-451-5939
    Email: commons@od.nih.gov

    Scientific/Research Contact(s)

    Judith Podskalny, PhD.
    National Institute of Diabetes and Digestive and Kidney Diseases,(NIDDK)
    6707 Democracy Blvd., Room 667
    Bethesda, MD 20892-5450)
    Telephone: 301-584-8876
    Email:podskalnyj@mail.nih.gov

    Peer Review Contact(s)

    Francisco O. Calvo, Ph.D.
    Chief, Review Branch
    National Institute of Diabetes and Digestive and Kidney Diseases
    6707 Democracy Boulevard, Room 752
    Bethesda, MD 20892-5452
    (for express/courier service: Bethesda, MD 20817)
    Telephone: (301) 594-8897
    Email: fc15y@nih.gov

    Financial/Grants Management Contact(s)

    Ms. Sharon Bourque
    Senior Grants Management Specialist
    National Institutes of Diabetes, Digestive, and Kidney Diseases (NIDDK)
    6707 Democracy Blulevard, Room 707
    Bethesda, Maryland  20892-5452
    (for express/courier service:  Bethesda, MD  20817)
    Telephone: 301-594-8846
    Email:bourques@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


    Weekly TOC for this Announcement
    NIH Funding Opportunities and Notices


    Office of Extramural Research (OER) - Home Page Office of Extramural
    Research (OER)
      National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
    9000 Rockville Pike
    Bethesda, Maryland 20892
      Department of Health and Human Services (HHS) - Home Page Department of Health
    and Human Services (HHS)
      USA.gov - Government Made Easy


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